GUEST COLUMNISTS

• A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science

  Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.

• The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target

  Antibody-drug conjugates (ADCs) are a type of targeted cancer therapy that combines the specificity of monoclonal antibodies with the potency of cytotoxic drugs. This article shares data surrounding the ADCs currently entering clinical trials, a look at failed ADC programs, and more.

• Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi

  It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.

• Best Practices For Cell Culture Media Fingerprinting

  This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available. 

• Add Efficiency From Development To Validation With Design Of Experiments

  A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.

• Dispelling 4 Common Myths Of Data Quality Governance

  Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

• Tackling Safety Issues Of Adjuvanted Vaccines

  An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.

• Draft FDA Labeling Guidance Proposes More Clarity For Providers

  The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape.